MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number UNK-NV-SAB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Ischemia (1942); Perforation (2001); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 08/15/2022

Event Type  Death  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Hao huang, jianping gu, haobo su, liang chen, xu he, jie kong, yadong shi, zhaoxuan lu, and yuan yuan; biomed research international; 2022; 6997221, 9; solitaire stent thrombectomy system in the treatment of acute lower-limb ischemia: comparisons in safety and effectiveness with conventional catheter-directed thrombolysis therapy; doi.Org/10.1155/2022/6997221.Medtronic received information in a literature article of patients treated with medtronic catheters and solitaire ab stents had compilations.The study aimed to investigate the safety and efficacy of the solitaire ab stent system for the treatment of acute lower extremity ischemia (alli) compared with conventional catheter-directed thrombolytic therapy. retrospective analysis of patients with alli treated at the study institution from january 2017 to april 2020 divided into a conventional (cdt) group (n = 106) and a percutaneous mechanical thrombectomy (pmt) group (n = 55) according to the procedure.The mean age of the patients was 72.51 years (range, 49¿93 years), and the study included 84 men (52.2%) and 77 women (47.8%). after treatment, the patients were followed up with at 1, 6, and 12 months.The primary outcome for analysis was the occurrence of any event of a composite clinical outcome (cco) during the first year after treatment (1).The occurrence of any of these events was considered an adverse outcome, and the patient was classified as reaching a primary outcome of this study.The components of the cco included (1) recurrent ischemia; (2) major amputation (above the ankle) or death; (3) life-threatening hemorrhage, either intracranial or blood loss, producing hypotension and requiring resuscitation; and (4) vascular complications such as perforation, occlusion, pseudoaneurysm, or dissection requiring unplanned or emergent surgical repair.Procedure: all procedures were performed under local anesthesia via the ipsilateral femoral artery or contralateral femoral artery approach.  after identifying the diseased blood vessels by lower-limb angiography on the lesion side, in the cdt group, a thrombolytic catheter was placed into the thrombotic segment and recombinant tissue plasminogen activator was subsequently given, followed by infusion with a dose of 0.4¿0.85mg/h through the thrombolytic catheter.Next, lower-limb arteriography was performed every 24 hour for re-examination.In the pmt group, a solitaire ab stent (6 × 30mm or 4 × 20mm) was applied to perform thrombus aspiration of the blood vessels of the diseased segment; then, cdt could be completed after the thrombus load of the diseased segment was relieved.A bolus injection of 5mg of rt-pa was administered intraoperatively, if necessary.During thrombolysis, daily detection of hematological indices was conducted, namely, blood cell counts, electrolyte levels, and renal and coagulation functions, and the fibrinogen content was measured at least once a day.The thrombolysis rate was adjusted according to the fibrinogen test results, and the hematological indices were re-examined at the end of thrombolytic therapy.When necessary, endovascular treatment could be used as an auxiliary technique (stent implantation or percutaneous transluminal balloon angioplasty) to restore artificial blood vessels, implants, or blood vessels to be unobstructed and to realize the full perfusion of distal blood vessels.Results: at the 1-year follow-up, the event rate for the cco in the cdt group was 26.4% compared to that of 9.1% in the pmt group.In terms of the cco, the groups showed significantly different rates of death (19.8% vs.7.3%) and life-threatening hemorrhage (15.1% vs.3.6%).Between the two groups, there was no significant difference in major amputation (3.8% vs.1.8%), ongoing/recurrent ischemia (1.9% vs.1.8%), or vascular complications (1.9% vs.1.8%).Two fasciotomies were performed following the completion of thrombolytic therapy in the cdt group.Moreover, five more patients in the cdt group and one patient in the pmt group developed an intracranial or gastrointestinal hemorrhage and died within days of their procedure.The percentage of patients who underwent stenting significantly differed between the cdt and pmt groups (45.3% vs.27.3%), and significant differences were found in thrombolytic duration (38:09 hours vs.24:56 hpurs) and recombinant tissue plasminogen activator (rt-pa) thrombolytic dose (19:34mg vs.13:55mg) between the groups.Technical success was achieved for 91 patients in the cdt group and 54 patients in the pmt group (85.9% vs.98.2%).

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17928290
• MDR Text Key: 325561178
• Report Number: 2029214-2023-02009
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SAB
• Device Catalogue Number: UNK-NV-SAB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Male